Neurology · 510(k) · 2025
TMINI Miniature Robotic System
THINK Surgical, Inc.. Cleared by FDA on 6 January 2025 under submission K243481, product code OLO (orthopedic stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K243481
- Device. TMINI Miniature Robotic SystemDEVICE
- Company. THINK Surgical, Inc.COMPANY
- Decision. 6 January 2025, 510(k), substantially equivalent (traditional review); received 8 November 2024DECISION
- Panel. NeurologyPANEL
- Product code. OLO, Orthopedic Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI Miniature Robotic System. The TMINI Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications: • Enovis EMPOWR Knee System • Ortho Development BKS and BKS TriMax Knee System • Total Joint Orthopedics Klassic Knee System • United U2 Total Knee System • Medacta GMK Sphere / SpheriKA Knee Systems • Zimmer Biomet Anterior & Posterior Referencing Persona Knee • b-ONE MOBIO Total Knee System • Maxx Orthopedics Freedom Total & Titan Knee • LINK LinkSymphoKnee System
The product code's definition, from FDA's classification record. Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 20,865 reports filed against devices carrying product code OLO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · REAMER HANDLE OFFSET · MAKO Surgical Corp. · report 3005985723-2026-00510
Screws loose Case Type / Application: THA 5.0.
30 September 2026 · Malfunction · Stealth AXiS · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01387
Medtronic received information regarding a navigation device being used intra-operatively during a sacroiliac and thoracolumbar procedure. It was reported that the trajectories could not be reached. All were marked as red. The site attempted to reposition to R-L5 and the trajectory guide ran into the patient reference frame clamped on L4. Surgeon grabbed the arm to stop it using the force sensor. Performed anatomy checks with probe to confirm accuracy. Accuracy was confirmed and the procedure […]
30 September 2026 · Malfunction · NAVLOCK · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01388
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that the probes tip broke. Delay and patient impact were not reported.
30 September 2026 · Injury · 5.5mm Tap, Navigation · Orthopediatrics · report 3006460162-2026-00057
29 September 2026 · Malfunction · REAMER HANDLE OFFSET · MAKO Surgical Corp. · report 3005985723-2026-00503
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OLO, in Neurology, from THINK Surgical, Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.